Lead, Quality Systems Validation (complaints / Adverse Events)

Johnson & Johnson Innovative Medicine

Horsham, Pennsylvania, United States of America
Base: $94,000.00 - $151,800.00; bonus/equity: not ...
Computerized system validation
Gxp systems
Regulatory compliance

Salary

Base: $94,000.00 - $151,800.00; Bonus/Equity: Not specified; Benefits: Retirement plan, 401(k), vacation, sick time, holiday pay, parental leave, etc.

Skills & Requirements

Must-have

  • Computerized System Validation
  • GxP systems
  • Regulatory Compliance
  • Project Management
  • Agile/SAFe
  • SDLC
  • Data Integrity

Nice-to-have

  • AI/ML
  • Digitalization
  • Cloud Computing
  • Cybersecurity
  • Risk-Based Approaches

Key Requirements

  • 6+ years of experience in pharmaceutical/medical device/biotech industry
  • Direct experience in Computerized System Validation
  • Experience in end-to-end Validation programs
  • Proficiency in JIRA, Qtest, Xray, Jenkins, Selenium
  • Thorough knowledge of cGMP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter